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Salary: EUR 60,212 - 105,200 / annual
DTX Pharma (a Novartis company) seeks a QA Compliance Expert to manage quality assurance within analytical and QC laboratories in Kundl, Austria. You will ensure operational compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements, and Novartis Quality Manual standards.
Key responsibilities include:
- Ensuring GxP compliance across in-process control (IPC) and QC release laboratories, analytical production labs, associated equipment, and IT systems; approving qualification plans and reports
- Monitoring life-cycle management including periodic reviews, change and deviation management, and risk assessments
- Supporting method validations and method transfers
- Assisting with regulatory inspections, customer audits, and responding to regulatory findings
- Collaborating with QC and eCompliance on planning new analytical lab systems, including the "Digital QC" initiative
- Implementing Novartis Quality Modules and regulatory requirements
- Contributing to standardization of GxP standards across the organization
Required qualifications:
- Completed degree in natural sciences or technical field (chemistry, microbiology, pharmacy, biotechnology) or equivalent multi-year professional experience
- Minimum 2 years professional experience, preferably in GMP-regulated pharma environments
- Initial experience with compliance in QA, QC, or production
- Fluent German and English
Novartis offers competitive base salary (€60,212–€105,200 annually), performance bonus/incentive programs, modern pension, childcare facilities, training and development programs, and global career opportunities. The company supports flexible work arrangements and home office options where feasible.
